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Active, not recruitingNCT04294199Updated Dec 18, 2023

Effect of Early Range of Motion Following First Time Patellar Dislocation

An interventional study of Early Range of MOtion in Patellar Dislocation, sponsored by Baylor College of Medicine. Active, not recruiting at 1 site in United States. Open to participants aged 11 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-12-18.

Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
11 Years to 17 Years
Sex
All
01

Study summary

Do teen-age patients with a dislocated knee cap do better with or without a brace?

Read the detailed description

This study will look at two different ways to treat teen-age patients who have had a dislocation of their knee cap. Both groups will receive the physical therapy treatment for knee cap dislocation but one group will first be in a brace for a week and the other group will start moving in therapy right away.

02

Conditions studied

  • Patellar Dislocation
03

Who can participate

Ages eligible
11 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Male and female adolescents between 11-17 years
  • Medical diagnosis of 1st time lateral patellar instability episode (dislocation or subluxation)
  • Subjective history of knee shifting, instability, popping out, knee effusion
  • Apprehension test is positive and has medial patellar tenderness
  • Referred to the Texas Children's Hospital (TCH) outpatient sports medicine clinic from an emergency room facility, urgent care or pediatrician within 10 days of the injury.
  • Free of co-morbidities that would prevent or limit rehabilitation including cardiac, pulmonary, psychiatric (except Attention Deficit Disorder (ADD) or Attention Deficit Hyperactivity Disorder (ADHD), orthopedic, neurological
  • Must be able to follow directions and participate in rehabilitation protocol for the 3-month study period.

Exclusion criteria

Exclusion Criteria:

  • Imaging or clinical findings suggest surgical intervention is needed i.e. fracture, osteochondral defect, Lachman or other positive knee ligament special tests.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Immobilization

    Patients in this group will be given a knee immobilizer to wear for 2 weeks and then receive outpatient physical therapy evaluation and treatment

    Other: Early Range of MOtion

  • Experimental
    Early range of motion

    Patients in this group will be allowed to move the knee and start outpatient physical therapy and treatment immediately.

    Other: Early Range of MOtion

Interventions

  • OtherEarly Range of MOtion

    Groups will be compared to see if immobilization or early range of motion is better at returning to their sport after patellar dislocation.

    Also known as: Immobilization, Ear;y Range of Motion

05

What researchers measure

Primary outcomes

  1. Kujala Knee Score

    13 item questionnaire to rate pain, function, ambulation, and instability

    Time frame: 10 minutes

  2. Tegner Activity Scale

    11 levels of activity from complete inability to function to advanced sports participation

    Time frame: 5 minutes

  3. Isokinetic Strength using Biodex

    Force of movement is measured in newtons and torque and corrected for body weight

    Time frame: 30 minutes

  4. Passive Range of Motion

    Measured with goniometer to record full range of motion in knee flexion and extension

    Time frame: 5 minutes

  5. Edema Assessment

    Measure of knee circumference

    Time frame: 2 minutes

Secondary outcomes

  1. Numerical Pain Rating Scale

    Pain rated by patient on scale of 0-10.

    Time frame: 1 minute

06

Study locations

1 site
  • Texas Children's Hospital
    Houston, Texas 77030, United States
07

References and documents

Publications

  • Erickson BJ, Mascarenhas R, Sayegh ET, Saltzman B, Verma NN, Bush-Joseph CA, Cole BJ, Bach BR Jr. Does Operative Treatment of First-Time Patellar Dislocations Lead to Increased Patellofemoral Stability? A Systematic Review of Overlapping Meta-analyses. Arthroscopy. 2015 Jun;31(6):1207-15. doi: 10.1016/j.arthro.2014.11.040. Epub 2015 Jan 28. PubMed 25636989 ↗
  • Armstrong BM, Hall M, Crawfurd E, Smith TO. A feasibility study for a pragmatic randomised controlled trial comparing cast immobilisation versus no immobilisation for patients following first-time patellar dislocation. Knee. 2012 Oct;19(5):696-702. doi: 10.1016/j.knee.2011.08.004. Epub 2011 Sep 29. PubMed 21962458 ↗
  • Saccomanno MF, Sircana G, Fodale M, Donati F, Milano G. Surgical versus conservative treatment of primary patellar dislocation. A systematic review and meta-analysis. Int Orthop. 2016 Nov;40(11):2277-2287. doi: 10.1007/s00264-015-2856-x. Epub 2015 Jul 23. PubMed 26202017 ↗
  • Cheng B, Wu X, Ge H, Qing Sun Y, Zhang Q. Operative versus conservative treatment for patellar dislocation: a meta-analysis of 7 randomized controlled trials. Diagn Pathol. 2014 Mar 18;9:60. doi: 10.1186/1746-1596-9-60. PubMed 24636710 ↗
  • Matic GT, Magnussen RA, Kolovich GP, Flanigan DC. Return to activity after medial patellofemoral ligament repair or reconstruction. Arthroscopy. 2014 Aug;30(8):1018-25. doi: 10.1016/j.arthro.2014.02.044. Epub 2014 Apr 24. PubMed 24768468 ↗
  • Vavken P, Wimmer MD, Camathias C, Quidde J, Valderrabano V, Pagenstert G. Treating patella instability in skeletally immature patients. Arthroscopy. 2013 Aug;29(8):1410-22. doi: 10.1016/j.arthro.2013.03.075. Epub 2013 May 25. PubMed 23714402 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT04294199
Lead sponsor
Baylor College of Medicine
Responsible party
Scott McKay (Principal Investigator, Baylor College of Medicine) — Principal investigator
First posted
Mar 4, 2020
Start date
Oct 31, 2018
Primary completion
Jun 15, 2024 (estimated)
Completion
Aug 11, 2026 (estimated)
Last update
Dec 18, 2023

Study contacts

Scott McKay, MD
principal investigator · Baylor College of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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